Generic Version of Fosamax Being Sought Through Citizen’s Petition

Clinical research firm Clinipace Worldwide wants the FDA to sign off on a generic version of Merck’s osteoporosis drug Fosamax by declaring that three strengths of the drug were not discontinued for safety or effectiveness reasons.

Clinipace filed a citizen’s petition with the FDA last month seeking the finding. The petition refers to an unnamed client that was interested in marketing a generic version of Fosamax (alendronate sodium) in all four dosage strengths.

Three of those strengths — 10 mg, 35 mg and 40 mg — are listed in the Orange Book as being discontinued by Merck on November, 2013, Clinipace says. By law, anyone interested in pursuing an ANDA on a reference product that has been discontinued needs a finding from the FDA that the drug was not pulled for reasons of safety or effectiveness.

If the drug was not pulled for those reasons, North Carolina-based Clinipace asks that its client’s Fosamax ANDA be accepted.

The FDA acknowledged receipt of the citizen’s petition in a letter to Clinipace filed on Regulations.gov. The agency also confirmed receipt of an ANDA on Fosamax along with the petition.

A number of generics firms, including Teva, Mylan and Apotex, are listed in the Orange Book as marketing various strengths of Fosamax, including the 70 mg version that Merck continues to list, which does not need a safety or effectiveness finding.

Fosamax has been the subject of lawsuits filed against Merck and the drug’s generic marketers alleging the product causes bone deterioration. Merck sought to settle some of those cases late last year. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.